Phase 1

Printer-friendly versionPrinter-friendly version

Before starting

  • Purchase the ISO 15189:2007 standard (CHF 136/about € 125 or $ 175). The GLI tool is completely based on the ISO 15189 standard and assists a laboratory in achieving ISO 15189 accreditation. Therefore, buying ISO 15189:2007 is a prerequisite.
  • Other standards and guidelines recommended to purchase:
    • ISO 9000:2005 (CHF 124/about € 115 or $ 160) provides the fundamentals of a quality management system and describes all the quality management specific terms.
    • ISO 9001:2008 (CHF 114/about € 105 or $ 150) formed the basis of the ISO15189. It explains the basics of a quality management system but is not laboratory specific.
    • ISO 15190:2003 (CHF 136/about € 125 or $ 175) provides the requirements of safety in the laboratory.
    • As this guide follows the framework of the CLSI GP26A4 Quality Management System: A Model for Laboratory Services; Approved Guideline (CHF 136/about € 125 or $ 175), it is recommended to purchase this guideline as well (available online, $ 200 non-member/$ 85 member price).

Further reading material:

Rieder HL et al. The public health service national tuberculosis reference laboratory and the national laboratory network. Minimum requirements, role and operation in a low-income country. Paris, International Union Against Tuberculosis and Lung Disease, 1998.

Laboratory biosafety manual, 3rd ed. Geneva, World Health Organization, 2004.

Goal phase 1

To ensure that the primary process operates correctly and safely.

The primary process is the total process of laboratory testing, from pre-analytical (the sample is collected, registered and processed) to analytical (the actual laboratory test) to post-analytical (the result is recorded, the report is made and sent to the clinician).

Description

In this phase the fundaments of a quality management system will be set up. The major activities include:

  • Formation of a quality project team.
  • Updating of background knowledge on quality management (i.e. through courses for both staff and management).
  • Development of Standard Operation Procedures for the laboratory tests to assure that TB testing is performed in a standardized manner, according to a defined methodology and with adequate respect for safety.
  • Development of Standard Operation Procedures and a maintenance schedule for the laboratory equipment to assure proper and safe use of equipment.
  • Upgrading of laboratory biosafety with appointment of a biosafety officer, biosafety training to all staff, biosafety assessment, and introduction of a biosafety manual.

NOTE: When certain steps in this phase cannot be completed yet due to external factors, but the remainder of the activities of phase 1 have been implemented, the laboratory may start with implementing phase 2 activities. Keep in mind that elements of phase 1 still need to be implemented.

Back to home
Go to Roadmap Phase 1
Go to Quality System Essentials overview Phase 1
  • Send by email